Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in pain intensity as measured by Numerical Rating Scale [NRS]
研究概览
简要总结
Spinal cord stimulation (SCS) or intrathecal drug delivery (pain pump) can be effective in providing pain relief for patients with low back pain who have not responded to other treatments. While both treatments, SCS and pain pump, may help with low back pain relief, it is not known which treatment may work better for patients. SCS and pain pumps involve an implanted device in the body.
In this study, we are asking patients to undergo a trial of both treatment modalities, SCS and pain pump, as screening tests prior to considering an implant. A total of 36 patients will be enrolled in this study. After both trials are completed, participants will be seen in the office and asked which treatment modality they believe has been more effective for relieving pain during the trial periods by completing questionnaires. If neither treatment was effective in improving baseline pain by at least 50%, participants would not qualify for either implant whether or not they are part of this study. Direct study participation would end here. If either or both treatment modalities improved baseline pain by at least 50%, participants will be asked to choose the treatment that worked better: SCS or pain pump. Participants will then have the option to proceed to the permanent implant of choice: SCS or pain pump. Direct study participation would end here but participants will then be followed in the doctor's office after implant as is customary for usual clinical care. The study data collection will conclude when the screening tests are completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 years or greater
- •Previous lumbar or thoracic spine surgery
- •Intractable pain of trunk (more than limbs; ≥ 75%/25% ratio back/leg pain)
- •Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications
- •Failed more conservative management, including physical therapy, medications and injections.
排除标准
- •Untreated infection or coagulopathy/patient unable to stop anticoagulants
- •Immune compromised state precluding having an implant
- •Allergic reactions to bupivacaine or fentanyl
- •Pregnancy.
- •Patients using > 15 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for 4 weeks or more before the prognostic test date
- •Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage resulting in difficulty ambulating
- •Patients deemed by Spine Surgery to be candidates for revision lumbar spine surgery
研究组 & 干预措施
Group A
SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours.
干预措施: Pain pump (Device)
Group A
SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours.
干预措施: Bupivacain 0.625%/Fentanyl 2mcg/ml (Drug)
Group A
SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours.
干预措施: Spinal Cord Stimulator (SCS) (Device)
Group B
IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test.
干预措施: Pain pump (Device)
Group B
IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test.
干预措施: Bupivacain 0.625%/Fentanyl 2mcg/ml (Drug)
Group B
IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test.
干预措施: Spinal Cord Stimulator (SCS) (Device)
结局指标
主要结局
Change in pain intensity as measured by Numerical Rating Scale [NRS]
时间窗: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group) 3, 6, 12 months for implanted patients
Numerical Rating Scale \[NRS\] is a numbered scale, from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Change in pain intensity as measured by Oswestry disability index [ODI]
时间窗: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
Oswestry disability index \[ODI\] is a questionnaire used to assess the impact of low back pain on a person's daily life. The ODI score ranges from 0 to 100, with lower scores indicating less disability.
Change in pain intensity as measured by painDETECT
时间窗: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
painDETECT is a nine-item questionnaire. A total score of 19 or more is indicative of likely neuropathic pain.
次要结局
- Number of adverse events as measured by patient report,(Up to 12 months)
- Change in daily opioid consumption as measured by Rx report(3, 6, 12 months)
- Change in quality of life as measured by the PROMIS-29.(Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients)
研究者
Salim M Hayek
Chief of the Division of Pain Medicine at University Hospitals
University Hospitals Cleveland Medical Center